inforMED

LAPKO

Received Jul 28, 1995 · Event occurred Feb 24, 1995

Report 26864 · MDR key 26864

Device

Generic name

Weight Machine

Manufacturer

Strive Enterprises

Model number

L1300

Catalog number

UNKNOWN

Lot number

UNKNOWN

Patient

41 YR

Narrative

Description of Event or Problem

DESCRIBED AS INDEX FINGER CRUSH INJURY WHEN SMASHED BETWEEN WEIGHTS DURING ADJUSTMENT WITH PIN. INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.